Verrica Pharmaceuticals Shares Drop 17% After FDA Complete Response Letter
September 21 2021 - 11:25AM
Dow Jones News
By Chris Wack
Verrica Pharmaceuticals Inc. shares were down 17% to $9.99 after
the company said the U.S. Food and Drug Administration has issued a
Complete Response Letter regarding its New Drug Application for
VP-102 for the treatment of molluscum contagiosum.
The company had previously disclosed that the FDA extended the
Prescription Drug User Fee Act goal date for the NDA by three
months to this Thursday, to allow the FDA additional time to review
information in response to comments regarding the company's human
factors study.
According to the CRL, the FDA has identified deficiencies at a
facility of a contract manufacturing organization, which are not
specifically related to the manufacturing of VP-102 but instead
raise general quality issues at the facility.
Verrica said that at no time prior to the CRL was it notified by
the FDA of any deficiencies at the CMO related specifically to the
manufacturing of VP-102 or that its general investigation of the
facility would have any impact on the company's NDA. Also, the FDA
didn't identify any clinical, safety or product specific chemistry,
manufacturing and controls deficiencies related to VP-102.
The company said the CMO has implemented corrective actions to
address the FDA's concerns, and the CMO has advised Verrica that it
is expecting a satisfactory resolution of the facility's identified
deficiencies from the FDA within the next 30 business days.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 21, 2021 11:10 ET (15:10 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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